Feasibility and Safety of a Powered Exoskeleton for Balance Training for People Living with Multiple Sclerosis: A Single-Group Preliminary Study (Rapper III).
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ABSTRACT: Objective
To evaluate the feasibility, usability, safety, and potential health benefits of using an exoskeleton device for rehabilitation of people living with multiple sclerosis.Design
Single-group preliminary study.Subjects
Eleven adults living with multiple sclerosis, with Expanded Disability Status Scores that ranged from 6 to 7.5 (mean age (standard deviation; SD) 54.2 (11.8) years), were recruited.Methods
Individual participants undertook a balance rehabilitation exercise programme using the Rex Rehab robotic exoskeleton device. Each participant undertook 4 × 45-60 min supervised, balance exercise sessions. Primary outcomes were: (i) the number of participants who completed the trial protocol safely, and (ii) the number and nature of adverse events reported. Secondary outcomes were: mobility; balance; spasticity; sleep; functional independence; quality of life; and device satisfaction.Results
Ten out of 11 participants completed the trial protocol safely. Four adverse events were recorded (1 serious), all of which were deemed unrelated to the trial. Secondary outcomes showed allied improvements in balance, joint mobility, spasticity and quality of life. All participants found the device acceptable to use.Conclusion
These results suggest that it is feasible and safe to use the Rex Rehab exoskeleton device to assist with balance rehabilitation for people living with multiple sclerosis.
SUBMITTER: Sakel M
PROVIDER: S-EPMC9774743 | biostudies-literature | 2022 Dec
REPOSITORIES: biostudies-literature
Publications
Feasibility and Safety of a Powered Exoskeleton for Balance Training for People Living with Multiple Sclerosis: A Single-Group Preliminary Study (Rapper III).
Sakel Mohamed M Saunders Karen K Hodgson Philip P Stephensen David D Phadke Chetan P CP Bassett Paul A PA Wilkinson David D
Journal of rehabilitation medicine 20221209
<h4>Objective</h4>To evaluate the feasibility, usability, safety, and potential health benefits of using an exoskeleton device for rehabilitation of people living with multiple sclerosis.<h4>Design</h4>Single-group preliminary study.<h4>Subjects</h4>Eleven adults living with multiple sclerosis, with Expanded Disability Status Scores that ranged from 6 to 7.5 (mean age (standard deviation; SD) 54.2 (11.8) years), were recruited.<h4>Methods</h4>Individual participants undertook a balance rehabilit ...[more]
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Project description:Background and purposeImpaired sensorimotor function, reduced physical activity and unemployment are common challenges in persons with multiple sclerosis (pwMS), even when disability is low. CoreDISTparticipation is a new, multidisciplinary intervention delivered across healthcare levels systematically addressing these elements. This study primarily aimed to evaluate the feasibility of CoreDISTparticipation in terms of process, resources, management, and scientific outcomes. The secondary aim was to evaluate initial efficacy in terms of possible short-term effects compared with the usual care on barriers to employment, balance, walking, health-related quality of life (HRQoL), and physical activity.MethodsThis assessor-blinded prospective pilot randomized controlled trial included 29 pwMS [Expanded Disability Status Scale (EDSS): 0-3.5] randomly allocated to the intervention group (CoreDISTparticipation) (n = 15) or usual care (n = 14). CoreDISTparticipation consists of three phases: (1) hospital outpatient clinic: MS nurse work-focused session and physiotherapist exploring balance; (2) municipality: a digital meeting with pwMS, employer, MS nurse, and physiotherapist addressing employment and physical activity, 4 weeks indoor CoreDIST balance training (60 min × 2/week); and (3) 4 weeks outdoor CoreDIST balance training and high-intensity running/walking (60 min × 2/week). Assessments were undertaken at baseline and at weeks 6 and 11. Primary feasibility metric outcomes were the reporting of process, resources, management, and scientific outcomes. Efficacy measures included evaluation of the Multiple Sclerosis Work Difficulties Questionnaire-23 Norwegian Version (MSWDQ-23NV) and 6 Minute Walk-test as well as the Trunk Impairment Scale-modified Norwegian Version, Mini-Balance Evaluation Systems Test (Mini-BESTest), Multiple Sclerosis Walking Scale-12, Multiple Sclerosis Impact Scale-29 Norwegian Version (MSIS-29NV), ActiGraph wGT3x-BT monitors, and AccuGait Optimized force platform. The statistical analyses included repeated-measures mixed models performed in IBM SPSS Version 29.ResultsThe primary feasibility metric outcomes demonstrated the need for minor adjustments in regard to the content of the intervention and increasing the number of staff. In regard to the efficacy measures, one person attended no postintervention assessments and was excluded, leaving 28 participants (mean EDSS: 1.8, SD: 1). The mean percentage employment was 46.3 (SD: 35.6) and 65.4 (SD: 39.3) in the CoreDISTparticipation and usual care group, respectively. No between-group differences were found. MSWDQ-23NV demonstrated a within-group difference of 5.7 points from baseline to Week 11 (P = 0.004; confidence interval: 2.2-9.3). Mini-BESTest and MSIS-29NV demonstrated within-group differences. The study is registered in ClinicalTrials.gov (Identifier: NCT05057338).DiscussionThe CoreDISTparticipation intervention is feasible to support pwMS when the identified feasibility metric outcomes in regard to process, resource, management, and scientific outcome metrics are adjusted to improve feasibility. Regarding efficacy measures, no between-group differences were detected; however, within-group differences in barriers to employment, balance, and HRQoL were detected for the CoreDISTparticipation group. A larger comparative trial is needed to explore between-group differences and should accurately and precisely define usual care and address the identified limitations of this study.
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Project description:BackgroundHypertensive disorders of pregnancy (HDP) are one of the greatest causes of perinatal morbidity and mortality. Mindfulness training (MT) significantly reduces blood pressure in non-pregnant adults, yet MT has not been tested to reduce blood pressure in the prenatal period.ObjectivesThe objectives of this pilot randomized clinical trial were to test the feasibility, acceptability, and effects of MT on rates of HDP among pregnant participants at risk for HDP. Exploratory analyses examined effects of MT on antenatal blood pressure.Study designParticipants were randomized to an 8-week phone-delivered MT intervention or usual care. Feasibility was defined by MT completion. Acceptability was defined by participants' satisfaction with the intervention. HDP outcomes were collected by medical chart review. Antenatal blood pressure values were extracted from medical records.ResultsTwenty-nine participants were randomized to phone-based MT (N = 15) or usual care (N = 14). 73% participants completed >5 MT sessions, indicating that MT was feasible. One hundred percent of participants indicated they were "satisfied" or "very satisfied" with the intervention, suggesting the intervention was acceptable. Rates of HDP were lower in the MT vs. usual care condition (9% vs. 29%; OR: 0.25, 95% C.I.: 0.02-2.65) although this did not reach statistical significance. Systolic and diastolic blood pressure levels were significantly lower at follow up among those randomized to MT vs. usual care.ConclusionsResults from this pilot trial suggest that prenatal MT is feasible and acceptable and may be a useful adjunctive preventative treatment for HDP among at-risk pregnant patients.Clinicaltrialsgov identifier is NCT03679117.
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Project description:BACKGROUND:Development of psychosocial group interventions for ovarian cancer survivors has been limited. Drawing from elements of cognitive-behavioral stress management (CBSM), mindfulness-based stress reduction (MBSR), and acceptance and commitment therapy (ACT), we developed and conducted preliminary testing of an Internet-based group intervention tailored specifically to meet the needs of ovarian cancer survivors. The Internet-based platform facilitated home delivery of the psychosocial intervention to a group of cancer survivors for whom attending face-to-face programs could be difficult given their physical limitations and the small number of ovarian cancer survivors at any one treatment site. OBJECTIVE:The aim of this study was to develop, optimize, and assess the usability, acceptability, feasibility, and preliminary intended effects of an Internet-based group stress management intervention for ovarian cancer survivors delivered via a tablet or laptop. METHODS:In total, 9 ovarian cancer survivors provided feedback during usability testing. Subsequently, 19 survivors participated in 5 waves of field testing of the 10-week group intervention led by 2 psychologists. The group met weekly for 2 hours via an Internet-based videoconference platform. Structured interviews and weekly evaluations were used to elicit feedback on the website and intervention content. Before and after the intervention, measures of mood, quality of life (QOL), perceived stress, sleep, and social support were administered. Paired t tests were used to examine changes in psychosocial measures over time. RESULTS:Usability results indicated that participants (n=9) performed basic tablet functions quickly with no errors and performed website functions easily with a low frequency of errors. In the field trial (n=19), across 5 groups, the 10-week intervention was well attended. Perceived stress (P=.03) and ovarian cancer-specific QOL (P=.01) both improved significantly during the course of the intervention. Trends toward decreased distress (P=.18) and greater physical (P=.05) and functional well-being (P=.06) were also observed. Qualitative interviews revealed that the most common obstacles participants experienced were technical issues and the time commitment for practicing the techniques taught in the program. Participants reported that the intervention helped them to overcome a sense of isolation and that they appreciated the ability to participate at home. CONCLUSIONS:An Internet-based group intervention tailored specifically for ovarian cancer survivors is highly usable and acceptable with moderate levels of feasibility. Preliminary psychosocial outcomes indicate decreases in perceived stress and improvements in ovarian cancer-specific QOL following the intervention. A randomized clinical trial is needed to demonstrate the efficacy of this promising intervention for ovarian cancer survivors.
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